Z-1501-2016Class II

CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and...

Name: Z-1501-2016 CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and...
Creator: Medtronic MiniMed Inc.
Published: 2016-02-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-02-19 / Terminated / root cause: manufacturing process

FDA source

Medtronic MiniMed Inc. began a recall of CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information on 2016-02-19. FDA classified it as Class II and gives the reason as "Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1501-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-19
Posted: 2018-10-11
Terminated: 2016-05-16
Recalling firm: Medtronic, Inc.
Product: CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Product code: OUG Medical Device Data System
Reason for recall: Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An Urgent Field Safety Notice was sent to customers on 2/19/16 to make customers aware of an iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 21 CareLink iPro reports. The letter informs customers that the affected CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The letter informs the customers of the requested next steps and to contact Maneesh Shrivastav, Director of Strategy at Medtronics Diabetes by email at [email protected] or call (763) 526-3509 if they have any questions.
Quantity in commerce: 20
Distribution: US: MN
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1501-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1501-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-15

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)